| CTRI Number |
CTRI/2021/01/030299 [Registered on: 06/01/2021] Trial Registered Prospectively |
| Last Modified On: |
05/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Metabolic Syndrome on Osteoarthritis Knee |
|
Scientific Title of Study
|
Association Of Metabolic Syndrome With Pain Intensity In Patients Of Osteoarthritis Knee |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rachit Gulati |
| Designation |
Senior Resident |
| Affiliation |
Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal |
| Address |
Department of Physical Medicine and Rehabilitation,
AIIMS, Bhopal Department of Physical Medicine and Rehabilitation,
AIIMS, Bhopal Bhopal MADHYA PRADESH 462020 India |
| Phone |
09829338844 |
| Fax |
|
| Email |
rachitgulati19@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rachit Gulati |
| Designation |
Senior Resident |
| Affiliation |
Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal |
| Address |
Department of Physical Medicine and Rehabilitation,
AIIMS, Bhopal Department of Physical Medicine and Rehabilitation,
AIIMS, Bhopal Bhopal MADHYA PRADESH 462020 India |
| Phone |
09829338844 |
| Fax |
|
| Email |
rachitgulati19@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sandeep Kumar Gupt |
| Designation |
Senior Resident |
| Affiliation |
Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal |
| Address |
Department of Physical Medicine and Rehabilitation,
AIIMS, Bhopal Department of Physical Medicine and Rehabilitation,
AIIMS, Bhopal Bhopal MADHYA PRADESH 462020 India |
| Phone |
09829338844 |
| Fax |
|
| Email |
drsandeep2k4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Blood Testing
Department of Pathology
All India Institute of Medical Sciences, Bhopal-462020 |
|
|
Primary Sponsor
|
| Name |
AIIMS BHOPAL |
| Address |
AIIMS
Saket Nagar
Bhopal |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rachit Gulati |
Department of Physical Medicine and Rehabilitation, AIIMS Bhopal |
All India Institute of Medical Scineces
Saket Nagar
Bhopal Bhopal MADHYA PRADESH |
09829338844
rachitgulati19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Bhopal Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Age ≥ 18 years.
2. Patients must satisfy the American College of Rheumatology (ACR) Clinical Classification Criteria for Osteoarthritis of the knee8
3. Presence of knee pain for three or more months.
4. Kellgren-Lawrence Grade for assessment of OA knee grade 1,2 and 3 |
|
| ExclusionCriteria |
| Details |
1. Recent Medical Infections
2. Current/Previous Joint infections
3. Other inflammatory joint disease (like Rheumatoid Arthritis)
4. Co-morbid Autoimmune disease
5. All cases of secondary OA
6. Previous interventions or surgery in Knee Joint
7. Previous/current history of trauma to knee joint
8. Kellgren-Lawrence Grade for assessment of OA knee grade 4 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Metabolic Syndrome has positive correlation with Osteoarthritis Knee Pain |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Metabolic Syndrome is prevalent in Osteoarthritis Knee patients |
6 months |
|
|
Target Sample Size
|
Total Sample Size="95" Sample Size from India="95"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis (OA) of the knee is a common chronic joint disease characterized by pain and significant restrictive disability due to gradual deterioration and inflammation of the articular cartilages. Overall prevalence of knee osteoarthritis in India is 28.7% with common risk factors being female gender, obesity, age and sedentary work.1 The pathophysiologic mechanisms of OA are under debate, but there is general agreement that biomechanics and increased dynamic loading of the joint are involved.2 However genetic, metabolic, and neuroendocrine factors have also been implicated in increased incidence of OA knee.3 It has been recently suggested that there is a chronic low grade systemic inflammation in OA knee which has led some authors to consider osteoarthritis to be part of a greater inflammatory metabolic syndrome.4 Metabolic Syndrome (MetS) comprises a number of conditions, including central obesity, atherogenic dyslipidemia, impaired fasting glucose and hypertension (HTN). It is prevalent in 33.5% Indians (24.9% males and 42.3% females).5 Obesity, besides causing higher mechanical load on knee joint, is also thought to be related to excessive proinflammatory cytokine production which could play a pathophysiologic role in OA .6 The atherogenic effects related to hypertension can also change the microvasculature of sub-chondral bone, thus leading to development of OA changes.7 However, despite the high prevalence of both MetS and OA knee in Indian population, there are limited studies regarding the association between these two and effect of MetS on the pain intensity of patients with OA knee. Therefore we have planned to conduct this study to determine the association between OA knee, MetS (and its various parameters) and Pain intensity (Visual Analogue Score) in a population based study of a sample of Indian Population (Rural and Urban) visiting a tertiary care hospital in Bhopal. |